The US Food and Drug Administration (FDA) has approved SKINVIVE by JUVÉDERM® (Allergan Aesthetics, an AbbVie company) for the reduction of neck lines and improvement of neck appearance in adults aged 21 years and older, according to an announcement from the company.
With the approval, SKINVIVE becomes the first and only hyaluronic acid (HA) injectable indicated to reduce the appearance of neck wrinkles while helping skin retain its natural moisture. According to Allergan Aesthetics, the treatment is designed to improve skin quality in the neck and address horizontal neck lines associated with aging, sun exposure, weight loss, and repetitive head-down positioning commonly referred to as “tech neck.”
“This approval expands our portfolio of lower face and neck treatment options and gives patients and aesthetic providers a first-of-its-kind treatment option for improving neck skin quality and reducing the appearance of neck lines,” said Darin Messina, PhD, senior vice president of aesthetics research and development at AbbVie, in a statement.
Pivotal Trial Demonstrated Improvement in Neck Lines
The approval was supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical trial evaluating SKINVIVE for horizontal neck lines. According to the company, 74.8% of treated participants achieved a clinically significant improvement of at least one point on the validated 5-grade Allergan Transverse Neck Lines Scale (ATNLS) at 1 month following treatment.
Among participants evaluated at 6 months, 66% maintained at least a 1-point improvement in neck lines. Investigators also reported that more than 78% of participants who demonstrated improvement from baseline maintained favorable overall scores throughout study follow-up.
Reported adverse events included injection-site redness, bruising, tenderness, lumps or bumps, swelling, firmness, pain, discoloration, and itching. Most events were mild, self-limited, and resolved within 2 weeks. Severe adverse events were reported in fewer than 5% of participants experiencing adverse events.
Allergan Aesthetics noted that the FDA has required provider training before purchase and administration of the product. The company expects broad commercial availability later this year.
